RecruitingNot Applicable

Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis

United States, Australia, Austria2,000 participantsStarted 2024-05-07

Plain-language summary

A prospective, observational post-market registry collecting outcomes through a 10-year post procedure follow-up for patients treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC Device) or the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE Device) as a part of routine clinical practice.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements
. Patient has been or is intended to be treated with an eligible registry device
. Patient is age ≥ 18 years at time of informed consent signature.

Exclusion criteria

. Patient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site's guidelines and procedures.
. Patient with exclusion criteria required by local law.
. Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Deployment Technical Success

Timeframe: Time of Surgery

Lesion-related Mortality

Timeframe: Day 30 through Year 10

Lesion Rupture

Timeframe: Time of Surgery through Year 10

Lesion Enlargement

Timeframe: Time of Surgery through Year 10

Endoleaks

Timeframe: Time of Surgery through Year 10

Device Migration

Timeframe: Time of Surgery through Year 10

Loss of aortic / branch patency

Timeframe: Time of Surgery through Year 10

New onset renal failure

Timeframe: Time of Surgery through Day 30

Trial details

NCT IDNCT06218875

SponsorW.L.Gore & Associates

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2042-09-30

Contact for this trial

Karen Martin

928-864-2223 kgmartin@wlgore.com

View on ClinicalTrials.gov More AAA - Abdominal Aortic Aneurysm trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements
. Patient has been or is intended to be treated with an eligible registry device
. Patient is age ≥ 18 years at time of informed consent signature.

Exclusion criteria

. Patient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site's guidelines and procedures.
. Patient with exclusion criteria required by local law.
. Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.

What they're measuring

Deployment Technical Success

Timeframe: Time of Surgery

Lesion-related Mortality

Timeframe: Day 30 through Year 10

Lesion Rupture

Timeframe: Time of Surgery through Year 10

Lesion Enlargement

Timeframe: Time of Surgery through Year 10

Endoleaks

Timeframe: Time of Surgery through Year 10

Device Migration

Timeframe: Time of Surgery through Year 10

Loss of aortic / branch patency

Timeframe: Time of Surgery through Year 10

New onset renal failure

Timeframe: Time of Surgery through Day 30